BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2871489 · Received December 5, 2012

    Report

    Report Number
    1627487-2012-11759
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 11, 2012
    Report Date
    November 11, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PT WAS HAVING A SPINAL FUSION OF TWO LEVELS. THE PT HAD PAIN AT THE IPG SITE AND HAD REQUESTED A SMALLER IPG. IN ADDITION, THE PT HAD NOT CHARGED THE IPG IN ABOUT 1 YEAR. IT WAS REPORTED, THE PAIN WAS DUE TO WEIGHT LOSS. THE PT WAS NO LONGER RECEIVING STIMULATION. F/U IDENTIFIED THE PHYSICIAN REPLACED THE IPG, AND PERFORMED THE FUSION. IT WAS REPORTED THE IMPEDANCE WERE NORMAL INTRAOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 119316

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention SCS LEAD: MODEL 3186| IMPLANT DATE: